Using implanted sensors for feedback control of implanted medical devices

ABSTRACT

A system and method for administering a therapeutic treatment to the heart includes a pressure sensor positioned in the pulmonary artery, an implantable medical device located remotely from the sensor, and communication means for communicating pressure data from the pressure sensor to the implantable medical device. The system includes a control module operatively coupled to the implantable medical device. The control module is adapted for comparing the pulmonary arterial pressure data to a pre-programmed value, adjusting an operating parameter of the implantable medical device based on the relationship of the pulmonary arterial pressure to the pre-programmed value, and repeating this process until the relationship between the pulmonary arterial pressure data and the pre-programmed value is such that no adjustment is necessary.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of co-pending U.S.application Ser. No. 11/223,398, filed Sep. 9, 2005, entitled “UsingImplanted Sensors for Feedback Control of Implanted Medical Devices,”which is incorporated herein by reference in its entirety for allpurposes.

TECHNICAL FIELD

The present invention relates to methods and devices for administeringcardiac therapy using implantable medical devices. More specifically,the invention relates to methods and devices for utilizing pulmonaryarterial pressure to control the operation of a cardiac therapy device.

BACKGROUND

As one skilled in the art will appreciate, blood pressure in the leftventricle, and in particular left ventricular end diastolic pressure, isa useful physiologic parameter for evaluating and monitoring cardiacperformance. This left ventricular pressure can serve useful inpredicting the onset of pulmonary edema in congestive heart failurepatients, monitoring and treating hypertension, optimizing the operationof cardiac rhythm management devices, and in rhythm discrimination.Unfortunately, the elevated fluid pressures in the left ventricleincrease the likelihood of hemorrhage during or following placement ofmonitoring equipment such as pressure sensors within the left ventricle.Furthermore, because blood flows directly from the left ventricle toother parts of the body, including the brain, the risk of stroke orvessel blockage from thrombi formed in the left ventricle issignificant. While pressure measurements within the right ventricle aremore easily obtained, and at lower risk than the left ventricle, theyare of less use in evaluating cardiac performance.

There is thus a need for a system for obtaining physiologic datarelatable to left ventricular end diastolic pressure, from a locationless susceptible to trauma than the left ventricle, to control theoperation of a remotely located implantable medical device.

SUMMARY

In one embodiment, the present invention is a system for administering atherapeutic treatment to the heart. The system includes a pressuresensor adapted for positioning in the pulmonary artery and collectingdata representative of at least one of systolic pressure, diastolicpressure, pulse pressure, heart rate or pre-ejection period based onpressure in the pulmonary artery. The system further includes animplantable medical device located remotely from the sensor and acontrol module operatively coupled to the implantable medical device andcommunication means for communicating pressure data from the pressuresensor to the control module. The control module is adapted forcomparing the at least one of systolic pressure, diastolic pressure,pulse pressure, heart rate or pre-ejection period to a pre-programmedvalue, adjusting an operating parameter of the implantable medicaldevice based on the relationship of the at least one of systolicpressure, diastolic pressure, pulse pressure, heart rate or pre-ejectionperiod to the pre-programmed value, and repeating this process until therelationship is such that no adjustment is necessary.

In another embodiment, the present invention is a method ofadministering a therapeutic treatment to the heart. Pulmonary arterialpressure is sensed from within the pulmonary artery with an implantedsensor. Data representative of the sensed pulmonary arterial pressure iscommunicated from the sensor to an implanted medical device. Apre-ejection period is calculated from the data. It is determined if thepre-ejection period is changing in relation to previously calculatedpre-ejection periods. If the pre-ejection period is changing, the heartrate is adjusted until subsequently measured pre-ejection periods arewithin an appropriate range.

According to another embodiment, the present invention is a method ofadministering a therapeutic treatment to the heart. Pulmonary arterialpressure is sensed from within the pulmonary artery with an implantedsensor. Data representative of the sensed pulmonary arterial pressure iscommunicated from the sensor to an implanted medical device. The data iscompared to a pre-programmed value relating to pulmonary arterialpressure. Increases in the heart's pacing rate are limited to maintainthe pulmonary arterial pressure below the pre-programmed value.

In yet another embodiment, the present invention is a method ofadministering a therapeutic treatment to the heart. Pulmonary arterialpressure is sensed from within the pulmonary artery with an implantedsensor. Data representative of the sensed pulmonary arterial pressure iscommunicated from the sensor to an implanted medical device. Heart rateand pulse pressure are calculated. It is determined if, based on heartrate and pulse pressure, a ventricular arrhythmia is occurring, and (2)if so, whether the ventricular arrhythmia is potentially lethal. If aventricular arrhythmia is present and is considered lethal, adefibrillation shock is administered. If a ventricular arrhythmia ispresent but is not considered lethal, an anti-tachy pacing protocol isadministered.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of a system for administering atherapeutic treatment to the heart, in accordance with an embodiment ofthe present invention, in relation to a heart.

FIG. 2 shows a cross-sectional view of a sensor device being held inplace in the pulmonary artery according to one embodiment of the presentinvention.

FIG. 3 shows another embodiment of an exemplary sensor anchoring devicefor use with the system of FIG. 1.

FIG. 4 shows a system for administering a therapeutic treatment to theheart in accordance with another embodiment of the present invention inrelation to a heart.

FIG. 5 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with an embodiment ofthe present invention.

FIG. 6 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with another embodimentof the present invention.

FIG. 7 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with another embodimentof the present invention.

FIG. 8 shows a system for administering a therapeutic treatment to theheart in accordance with another embodiment of the present invention inrelation to a heart.

FIG. 9 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with another embodimentof the present invention.

FIG. 10 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with another embodimentof the present invention.

FIG. 11 is a flowchart illustrating a method of administering atherapeutic treatment to the heart in accordance with another embodimentof the present invention.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

The present invention relates generally to a method and system foradministering a therapeutic treatment to the heart, and morespecifically to a method and system in which blood pressure measurementsare obtained and incorporated into the closed-loop control of a remotelylocated implantable medical device. As one skilled in the art willappreciate, blood pressure can be obtained from a number of differentlocations, such as the pulmonary artery, the aorta, anywhere in thearterio-venous system, or many locations distal from the heart.Different symptoms and/or diseases can be determined by measuringpressure at different locations. Furthermore, a measurement of pressureat one location can be indicative of or relatable to a physiologicparameter at a second location. Thus, the present invention is notlimited to detecting pressure at any particular location. However, forease of discussion, the methods and systems will be described withreference to placing sensors in the pulmonary artery.

FIG. 1 shows a system 10 for administering a therapeutic treatment inrelation to a human heart 20 in accordance with an embodiment of thepresent invention. As shown in FIG. 1, the heart 20 includes a pulmonaryartery 22, which carries deoxygenated blood from a right ventricle 24 tothe lungs (not shown). Fluid flow into the pulmonary artery 22 isregulated by the opening and closing of the passive pulmonary valve 26.When the right ventricle 24 contracts during systole, the pulmonaryvalve 26 opens and blood flows into the pulmonary artery 22. When theright ventricle 24 relaxes during diastole, the pulmonary valve 26closes to prevent backwash of blood from the pulmonary artery 22 intothe right ventricle 24. The increase or decrease of fluid pressurewithin the pulmonary artery 22 corresponds to the opening and closing ofthe pulmonary valve 26, which directly follows contractions of the rightventricle 24. Thus, among other things, the rise and fall of bloodpressure within the pulmonary artery 22 provides an accurate measure ofright side pacing of the heart 20. Oxygenated blood flows from the lungsinto a left atrium 28 and into a left ventricle 30 of the heart 20. Theleft ventricle 30 in turn pumps the oxygenated blood out the aorta tothe rest of the body.

The system 10 includes an implantable medical device (IMD) 32 incommunication with a pressure sensor unit 34 positioned in the pulmonaryartery 22. Exemplary IMDs 32 for use in conjunction with the presentinvention include implantable cardiac devices, such as pacemakers,defibrillators, ventricular assist devices (VADs), drug pumps, cardiacresynchronization therapy (CRT) devices, and stand-alone diagnosticdevices for enhancing the utility of tachycardia and bradycardia devicesrelative to disorders such as vasovagal syncope. Other exemplary IMDs 32are devices used for post-implant monitoring of the functionality ofpassive devices like septal plugs and artificial valves.

In the embodiment shown generally in FIG. 1, the IMD 32 is a cardiacrhythm management device including a pulse generator 36 implantedsubdermally in the upper chest or abdomen and an electrical lead 38extending from the pulse generator 36 into the heart 20 for sensing orpacing the heart 20. The IMD 32 further includes receiving communicationmeans 40 for receiving data from the pressure sensor 34 and a controlmodule 42 for interpreting the data from the sensor unit 34 andcontrolling at least part of the IMD 32 operation. The communicationmeans 40 and control module 42 may be located in a housing 44 along withthe pulse generator 36. The control module 42 is operatively coupled tothe IMD 32 and controls and adjusts the operating parameters of the IMD32.

As is shown in FIG. 1, the pressure sensor unit 34 is positioned in thepulmonary artery 22. The pressure sensor unit 34 includes a sensor ortransducer 45 for obtaining pressure data and sending communicationmeans 46 for communicating data from the sensor 34 to the IMD 32.

Exemplary sensors and sensor configurations are described in more detailin the following four co-pending patent applications: U.S. patentapplication Ser. No. 10/943,626 entitled “SYSTEMS AND METHODS FORDERIVING RELATIVE PHYSIOLOGIC PARAMETERS,” filed Sep. 17, 2004; U.S.patent application Ser. No. 10/943,269 entitled “SYSTEMS AND METHODS FORDERIVING RELATIVE PHYSIOLOGIC PARAMETERS USING AN EXTERNAL COMPUTINGDEVICE,” filed Sep. 17, 2004; U.S. patent application Ser. No.10/943,627 entitled “SYSTEMS AND METHODS FOR DERIVING RELATIVEPHYSIOLOGIC PARAMETERS USING A BACKEND COMPUTING SYSTEM,” filed Sep. 17,2004; and U.S. patent application Ser. No. 10/943,271 entitled “SYSTEMSAND METHODS FOR DERIVING RELATIVE PHYSIOLOGIC PARAMETERS USING ANIMPLANTED SENSOR DEVICE,” filed Sep. 17, 2004. All of theabove-identified patent applications are hereby incorporated byreference.

The sensor unit 34 further includes an anchoring system 48 for anchoringthe pressure sensor 34 in the pulmonary artery 22. FIG. 2 shows aportion of the sensor unit in accordance with one embodiment of thepresent invention. The sensor 62 includes one or more fins or extensions64 that can facilitate the anchoring of sensor 62 in the pulmonaryartery 22. The sensor unit can be positioned within the pulmonary artery22 and initially anchored or held in place using an expandablestent-like device 66. The stent-like device 66 can be any suitable stentdevice or other anchoring device currently known or hereinafterdeveloped.

FIG. 3 shows a portion of a sensor unit according to another embodimentof the present invention. As shown in FIG. 3, the sensor unit 80includes an anchoring device 82, a sensor 84, and one or more connectionstructures 86 for connecting the sensor 84 to the anchoring device 82.In this particular embodiment, the connection structures 86 areconfigured to secure the sensor 84 so that the sensor 84 will residenear the middle of the pulmonary artery 22, as opposed to the anchoringstructure discussed above that position the sensor near the vessel wall54. By placing the sensor 84 near the middle of the pulmonary artery 22,the sensor 84 will reside in the predominant blood flow that occurs inthe middle of the pulmonary artery 22, avoiding edge effects, such asslower blood flow, dead zones, and perhaps clotting issues.

In one embodiment, the sensor unit 60, including the sensor 62 and theextensions 64, is formed from a bio-compatible material, such asstainless steel, titanium, Nitinol, or some other bio-compatiblematerial. In yet other embodiments, the sensor unit can be coated withDacron®, nylon, polyurethane or other material that promotes theformation of a layer of endothelial tissue over the device. In stillother embodiments, the sensor unit 60 can be coated with one or moredrugs to reduce inflammation and/or induce endothelialization. Suchdrugs are currently known in the art.

The sensor unit can be positioned and secured in the pulmonary artery 22using techniques similar to a Swan-Ganz technique, or other similarcatheterization techniques, which is further described in co-pendingU.S. patent application Ser. No. 10/970,265, entitled “Delivery Systemand Method for Pulmonary Artery Leads,” filed Oct. 21, 2004, which ishereby incorporated by reference.

As shown in FIG. 1, the sending communication means 46 of the pressuresensor 34 and the receiving communication means 40 of the IMD 32 may bewireless, in which case the IMD 32 and the pressure sensor 34 are notphysically connected. Suitable sending communication means 46 andreceiving communication means 40 include acoustic, ultrasonic and radiofrequency wireless communication modules in communication with andoperatively coupled to the pressure sensor 45 and control module 42,respectively. Such communication modules can further include shieldingand antennas for facilitating the transfer of data and reducingbackground noise and interference.

FIG. 4 shows another embodiment, however, in which the sendingcommunication means 46 and receiving communication means 40 are providedvia a physical connection between the pressure sensor 45 and the IMD 32.In this embodiment, the sending communication means 46 and receivingcommunication means 40 are an electrical lead 130 extending from thepressure sensor 34 in the pulmonary artery 22, through the pulmonicvalve 26, to the IMD 32. In other embodiments, the sending communicationmeans 46 and the receiving communication means 40 are provided by afiber optic connector.

The pulmonary arterial pressure sensor unit 34 is used to gather dataconcerning the amplitude, timing and/or morphology of blood pressurewithin the pulmonary artery 22. The sensor unit 34 may be used tomonitor sudden changes in pressure or other critical events or to gatherdata over longer periods of time to determine cardiac performancetrends. The sensor unit 34 may be programmed to continuously monitorpressure within the pulmonary artery 22, to sample pressure within thepulmonary artery 22 periodically, or to commence monitoring or samplingwhen a secondary event transpires. For example, the sensor 45 could beawakened or activated based on sensed heart rate or indications fromother sensor(s). Alternately, the pulmonary arterial sensor 45 may beexternally controlled, based on other sensor information or time, toreduce power consumption. In one embodiment, a measure of atmosphericpressure is provided to the sensor unit 34 to allow it to correct foratmospheric pressure in the generation of an accurate pulmonary arterialpressure reading.

Information about physiologic parameters such as blood pressure withinthe pulmonary artery 22 has intrinsic value in evaluating the mechanicaloperation and other characteristics of the cardio-pulmonary system.However, information about physiologic parameters within the pulmonaryartery 22 can also be used to obtain information about secondaryphysiologic parameters. For example, as is known in the art, pressuresmeasured in the pulmonary artery 22 can be reflective of end diastolicpressures on the left side of the heart 20 and within the left ventricle30. Both pulmonary arterial end-diastolic pressure and mean pulmonaryarterial pressure can be correlated with left ventricular end-diastolicpressure.

The correlated secondary physiologic parameter data, in this embodimentleft ventricular end diastolic pressure data, may then be used toevaluate and monitor cardiac performance for use in controlling at leastpart of the operation of the IMD 32. Pressure data from the sensor unit34 may be compared alone or in conjunction with other inputs the IMD 32may have collected or been programmed with to a pre-programmed value orrange. The relationship between the pressure data and any other inputsto the pre-programmed value or range may be used by the control module42 to adjust the operating parameters of the IMD 32. The system 10 cancontinue to adjust the operating parameters of the IMD 32 as therelationship changes following the administration of a therapeutictreatment (i.e., the change in the operating parameters of the IMD 32)until the relationship is acceptable or until the relationship is suchthat further therapeutic treatment is unnecessary or prohibited, or asatisfactory outcome is reached. In this manner, the system 10 providesrelatively straightforward closed-loop applications to control IMD 32parameters and operation, and more specifically provides a closed-loopsystem for administering a therapeutic treatment to the heart 20 via theIMD 32.

The following examples describe various applications for administering atherapeutic treatment via system 10.

FIG. 5 is a flowchart illustrating a method 160 of administering atherapeutic treatment to the heart 20 in accordance with anotherembodiment of the present invention. In general, sick or diseased heartsdo not beat as rapidly as healthy hearts. As a result, there must bemore time between heartbeats for the pressure to decrease to a normalrange of diastolic pressure (approximately 6-13 mmHg) in the pulmonaryartery 22. An increase in heart rate will thus increase the pulmonaryarterial diastolic pressure (PADP) in these patients into a range(approximately greater than 15-20 mmHg) where the patient would sufferdyspnea (abnormal or uncomfortable breathing). Simply reducing the ratewill alleviate some of these symptoms, although, obviously, the patientwill still have reduced exercise capacity, since reducing the maximumheart rate will reduce the maximum cardiac output attainable.

In the present method, the PADP is monitored (block 162) and data iscommunicated to the control module 42 in the IMD 32 (block 164). Thecontrol module 42 is adapted to control and adjust the pacing rate ofIMD 32 based upon the relationship between the diastolic pressure and apre-programmed value based upon normal or desired diastolic pressure.The pre-programmed value may be set by the physician or may bedetermined by the control module 42 based upon historic diastolicpressure measurements. In one embodiment, the control module 42 comparesthe PADP to the pre-programmed value and limits increases in the pacingrate of a cardiac rhythm management device (i.e., IMD 32) that wouldincrease the pulmonary arterial diastolic pressure above thepre-programmed value (blocks 168 and 169). This application provides asymptom (i.e., increasing pulmonary arterial diastolic pressure) limitedupper rate of the operation of the IMD 32 and can reduceexercise-induced dyspnea. Since other factors such as blood volume andposture can affect the PADP, the sensor based approach to rate controlas just described will be more effective than simply programming a lowervalue for the upper rate limit (e.g., 100 beats/minute). This processmay be repeated continuously or as needed to achieve a satisfactoryoutcome or relationship, i.e., to prevent exercise-induced dyspnea, orwhen the relationship between the diastolic pressure and thepre-programmed value is such that no further adjustment in IMD 32operating parameters is desired.

FIG. 6 is a flowchart illustrating a method 170 of administering atherapeutic treatment to the heart 20 according to yet anotherembodiment of the present invention. In the present embodiment,pulmonary arterial pulse pressure is monitored to identify potentiallylethal ventricular arrhythmias, for example, ventricular tachycardias.

Ventricular tachycardias are sensed by implantable medical devices suchas defibrillators in one of two ways: (1) by looking for a sustainedheart rate that exceeds a pre-programmed value (e.g., 220 beats/minute)or (2) by looking for a sustained heart rate that exceeds a lowerpre-programmed value (e.g., 180 beats/minute) but reaches this heartrate very quickly (e.g., a rate increase of 60 beats/minute in less thanfive seconds).

In addition to these criteria, if the pre-ejection period doesn'tshorten significantly (e.g., greater than ten percent shortening) or ifthe systolic pulmonary arterial pressure simultaneously drops (e.g.,greater than ten percent decrease), then the device could be relativelycertain that the patient is experiencing a ventricular arrhythmia. Ifthe decrease in systolic pulmonary arterial pressure were even greater(e.g., greater than fifty percent), this would indicate that the patientis unconscious and in serious danger and should receive a shockimmediately to correct the arrhythmia. However, the shock could bedelayed and the device could go through a series of anti-tachy pacingprotocols if the systolic pulmonary arterial pressure remained above thethreshold value.

Thus, pressure data from the pressure sensor unit 34 is gathered (block172) and communicated to the control module 42 in the IMD 32 (block174). The control module 42 is adapted to calculate the heart rate basedupon changes in pulmonary arterial pressure over time (block 176) orfrom the intracardiac electrogram sampled from lead 38. Based upon therelationship between the calculated heart rate, diastolic pressure and apre-programmed value or range, the control module 42 is further adaptedto adjust and control the operating parameters of the IMD 32. In oneembodiment, if along with a sudden increase in heart rate (block 178),the measured systolic pressure or pulse pressure drops by apre-programmed percentage or absolute value (block 180), the ventriculararrhythmia is considered to be potentially lethal and the IMD 32administers a defibrillation shock as soon as possible (block 182).However, if the arrhythmia is not considered immediately lethal, ananti-tachy pacing protocol may be implemented via the IMD 32 to convertthe patient less traumatically (block 184). This will potentially reducethe incidence of “unnecessary” shock treatment. Thus, based on therelationship between the PADP, heart rate and pulmonary arterialsystolic or pulse pressure, which may be based on historic measurements,the control module 42 instructs the IMD 32 as to the appropriate courseof action to adjust the IMD 32 operating parameters. This process may berepeated or looped until a satisfactory outcome or relationship betweenthe sensed PADP, heart rate, pulse pressure or systolic pressure isachieved or maintained, or until the relationship between the diastolicpressure and the pre-programmed value is such that no further adjustmentin IMD 32 operating parameters is desired.

FIG. 7 is a flowchart illustrating a method 186 of administering atherapeutic treatment to the heart 20 in which atrial ventricular (“AV”)delay is optimized for cardiac resynchronization therapy. PADP ismonitored periodically by the pressure sensor 34 (block 187) andpressure date is communicated to the control module 42 in the IMD 32(block 188). The relationship between the sensed PADP and apre-programmed value relating to optimal or normal PADP, which may bebased on historic measurements, is employed by the control module 42 tocontrol the operating parameters of the IMD 32. In one embodiment, ifthe PADP is above a pre-programmed value relating to a normal or upperlimit (usually 15-20 mm Hg) (block 189), the IMD 32 adjusts the AV delayuntil the diastolic pressure in the pulmonary artery 22 is reduced to anappropriate value. In one embodiment, the AV delay is first decreased(block 190). The PADP is sampled (block 191) and communicated to the IMD32 (block 192). If the PADP has also decreased (block 193), the processis repeated in increments until a minimum steady-state PADP is reached(block 194). On the other hand, if decreasing the AV delay isaccompanied by an increase in the PADP, then the AV delay is increased(block 195). The PADP is sampled (block 196), communicated to the IMD 32(block 197) and repeated in increments until a minimum PADP is reached(198). This process may be repeated or looped until a satisfactoryoutcome or relationship between the sensed PADP and the pre-programmedvalue is achieved or maintained, or until the relationship between thediastolic pressure and the pre-programmed value is such that no furtherchange in IMD 32 operating parameters is desired.

In another embodiment of the present invention, the system includes asecondary sensor located remotely from the pulmonary arterial sensor.FIG. 8 shows a system 200 including an implantable medical device 232 incommunication with a remotely located pressure sensor 234 positioned inthe pulmonary artery 22 and a secondary sensor 235 located remotely fromthe pulmonary arterial sensor 234. The secondary sensor 235 is adaptedfor measuring a physiologic parameter, for example, blood pressure, atthe second location. The secondary sensor 235 is also in communicationwith a control module 242 of the IMD 232. Information about thephysiologic parameter received from the secondary sensor 235 may be usedby the control module 242 in conjunction with information received fromthe pulmonary sensor 234 to control operation of the IMD 232. As isshown in FIG. 9, in one embodiment the secondary sensor 235 is apressure sensor located in the aorta 31.

FIG. 9 is a flowchart illustrating a method 240 of administering atherapeutic treatment to the heart 20 in accordance with an embodimentof the present invention. The pressure sensor unit 34 detects thepressure within the pulmonary artery (block 243) and communicatespressure data to the control module 42 in the IMD 32 (block 244). TheIMD 32 is also in communication with a secondary sensor (block 246). Thesecondary sensor may be, for example, an electrical lead positionedwithin a ventricle and adapted for sensing electrical activity withinthe ventricle. The control module 42 is adapted to determine thepre-ejection period based upon the pressure data communicated from thesensor unit 34 and the electrical data communicated from the lead (block248).

It is known that changes in pre-ejection period, measured as the timebetween ventricular electrical sensing or pacing to the beginning of theincrease in pulmonary arterial pressure (corresponding to the beginningof right ventricular ejection upon opening of the pulmonic valve 26),are indicative of changes in sympathetic tone. Specifically, a reducedpre-ejection period is indicative of an increase in sympathetic tone asa result of increased workload or emotional stress requiring increasedcardiac output, which can be achieved by increasing the heart rate.Thus, pulmonary arterial pressure data can be correlated to thepre-ejection period, which can in turn be employed to control the heartrate to prevent, reduce or reverse increases in sympathetic tone. Areasonable relationship for determining pacing cycle length, and thusheart rate, is A times the pre-ejection period plus B. Constants A and Bwould be individually programmed for each patient and could bedetermined during a short period of exercise.

Returning to FIG. 9, the control module 42 is adapted to control the IMD32 to adjust pacing cycle length based upon the relationship between thecalculated pre-ejection period and a pre-programmed value or rangerepresenting a normal or desirable pre-ejection period. Thispre-programmed value may be based upon historic diastolic pressuremeasurements. In one embodiment, if the pre-ejection period is below anacceptable pre-programmed value or range (block 250), the control module42 instructs the IMD 32 to decrease the pacing cycle length, increasingthe heart rate (block 252) until the pre-ejection period returns to anacceptable value or range in relation to the pre-programmed value.

A sudden step increase in the pre-ejection period may indicate a “lossof capture.” Loss of capture occurs when the stimulating pulse deliveredby a pacing device such as IMD 32 does not depolarize a sufficientvolume of tissue to result in a “wave of activation” over the entireheart 20 to activate a cardiac contraction. This can happen if theelectric field across the myocardial cell membrane in the myocardiumclosest to a pacing electrode is of insufficient strength to depolarizethe cells.

If the patient is being paced in an atrial synchronous mode, as in CRT,(i.e., the device senses an atrial depolarization, waits for theduration of the programmed AV delay, and then paces the ventricle), thenloss of capture will usually result in an increased pre-ejection period.However, if the patient is being paced in a single-chamber mode(indicating that the atrium is not sensed), then, since the intrinsicventricular rhythm and the paced rhythm are totally asynchronous, a lossof capture will merely increase the variability within the pre-ejectionperiod with some decreased and some increased values. In the first case,a sudden (i.e., from one heart-beat to the next) increase inpre-ejection period having a magnitude of either ten percent or morethan two standard deviations from the previous mean value, would besufficient to indicate loss of capture. In the second case, both anincrease and a decrease in pre-ejection period of the same magnitudewould indicate loss of capture.

In another embodiment, upon determining that a loss of capture hasoccurred based on the relationship between the pre-ejection period and apre-programmed value representing previous pre-ejection periods, the IMD32 increases pacing output until the previous or an appropriatepre-ejection period is regained. This indicates that the stimulatingpulse delivered by the IMD 32 is depolarizing a sufficient volume oftissue to result in a “wave of activation” over the entire heart 20 toactivate a cardiac contraction.

Another application of system 200 is shown in FIG. 10, a flowchartillustrating a method 260 of administering such a therapeutic treatmentto the heart 20, in which the AV delay is adjusted so that the openingof the pulmonic valve 26, which is indicated by a sudden increase inpulmonary arterial pressure, is simultaneous with the opening of theaortic valve. Pulmonary arterial pressure is measured (block 261) anddata is communicated to the IMD 232 (block 262). The timing of thepulmonic valve 26 is calculated from cyclical sudden increases inpulmonary arterial pressure (block 264). The timing of the beginning ofthe pressure increase in the pulmonary artery can also be determined bylooking for a peak in the first derivative of the pulmonary arterialpressure waveform. The beginning of left ventricular ejection may bedetermined from a secondary sensor 235 adapted to sense left ventricularheart sounds, for example, S1, or the beginning of left ventricularvolume decrease, which is measured by impedance across the leftventricle 30, or by the beginning of aortic or arterial flow determinedby ultrasound or impedance or by a pressure sensor in the descendingaorta or other artery (block 265).

Based upon the relationship between the calculated AV delay (based uponthe diastolic pressure) and a pre-programmed value representing a normalor desirable AV delay, the control module 42 is adapted to control theoutput of the IMD 32. In one embodiment, the timing of the pulmonicvalve and the timing of the aortic valve are compared (block 266) and ifthe difference is not equal to a pre-programmed value, the IMD 232progressively lengthens or shortens the AV delay (block 268). Thisprocess may be repeated until the relationship between the diastolicpressure and the pre-programmed value is such that no further change inoperating parameter is desired. In one embodiment, the process isrepeated until the difference in time between the two events isminimized or reaches a pre-programmed value (block 266).

In another embodiment of the present invention, the system 10 isemployed during follow-up care under physician guidance to optimize IMDoperational programming. For example, the system 10 is employed tocontrol AV delay or pacing site(s) in an IMD programming change tooptimize right heart function during cardiac rhythm therapy bymonitoring pulmonary arterial end diastolic pressure or pulmonaryarterial pulse pressure. Virtually any change in therapy that decreasesPADP that is above a pre-programmed value or range (approximately 15-20mmHg), other than merely decreasing heart rate, is likely to be a goodchange, provided that pulse pressure does not simultaneously decrease.The impact of a programming change to the IMD 32 may be monitored overan extended time period (days or weeks) to determine whether theprogramming change was successful.

According to another embodiment, the pressure sensor unit 34 is also incommunication with an external device. Such external devices may includemonitoring, diagnostic or telemetry equipment. Such external equipmentmight also be in communication with the IMD 32 such that in addition toclosed-loop control, a physician is able to monitor physiologicparameters of the pulmonary artery 22 and provide additional IMDoperational inputs, such as programming changes.

A pulmonary arterial pressure sensor permits the real-time measurementof parameters related to important left heart parameters withoutactually being in the left ventricular blood volume. A sensor in thepulmonary artery 22 rather than the left ventricle 30 reduces the chanceof thrombosis and permits accurate measurement of systolic intervals,such as pre-ejection period and ejection time, that are more difficultto estimate from the right ventricle 28. Further, the pulmonary artery22 is more easily accessed and placement of the pulmonary sensor 34 isless likely to result in trauma to the heart 20 than placement in theleft ventricle 30.

A significant benefit of the present invention is that throughmonitoring pressure in the pulmonary artery 22, the IMD 32 candiscriminate lethal arrhythmias from those that are less dangerous,permitting the use of anti-tachy pacing protocols that may convert therhythm without a large shock, thereby minimizing the risk ofadministrating painful shocks to conscious patients. This is donewithout resorting to sophisticated and inaccurate algorithms thatattempt to make this discrimination based on the morphology of theintracardiac electrogram.

A system and method in accordance with the present invention may beemployed to administer substantially any therapeutic treatment to theheart, as well as to monitor the performance and efficacy of implantablemedical devices.

In one embodiment, IMD 32 is an implantable drug infusion device adaptedfor controlling delivery of a drug, such as a diuretic for reducingtotal fluid volume. The control module 42 may be adapted for controllingthe volume and rate of drug delivery. FIG. 11 is a flowchartillustrating a method 300 for administering a drug such as furosemide,trade name Lasix™, for the treatment of decompensated heart failure,according to one embodiment of the present invention. The pressuresensor 34 takes pressure sensor readings (block 302) and communicatesdata representative of the pulmonary arterial diastolic pressure to thecontrol module (block 304). Because blood pressure often increasesduring periods of activity, the PADP of a patient suffering from leftventricular dysfunction can increase from an average of 6-13 mmHG whileat rest to an average of 20-30 mmHG when active. Thus, the controlmodule 42 is adapted to first determine whether the patient is at restor is active. This may be accomplished by monitoring activity levelswith an accelerometer or by monitoring heart rate. Heart rate may bemonitored with a separate sensor, or may be determined from the sensedpulmonary arterial pressure waveform.

When it is determined that the patient is at rest (block 306), thesensed PADP is compared to a pre-programmed value or threshold fordesired PADP (block 308). The pre-programmed value can be chosenaccording to the patient's sex, height, weight and age, and according tohistoric PADP measurements. The control module 42 is adapted to instructthe IMD 32 to infuse drugs into the patient based upon the relationshipbetween the diastolic pressure and the pre-programmed value. In oneembodiment, if the resting PADP exceeds the pre-programmed value,infusion of the medication is commenced (block 312). Prior to infusingany drug, however, the control module 42 is adapted to determine whetherthe maximum daily dosage has been infused (block 310). If so, anyfurther drug infusion is halted. The system 10 may continue to monitorPADP, may cease to monitor PADP and simply go into a resting mode, ormay be provided with means to indicate the maximum daily dosage has beeninfused or to sound an alarm if the PADP remains above the threshold. Inone embodiment, 80 mg of furosemide is infused. In one embodiment, themaximum dosage may be set at 800 mg of furosemide. Again, however, themaximum dosage varies depending on the patient's physicalcharacteristics, medical history, and drug formula.

In one embodiment, approximately 80 mg of furosemide is infused at eachinfusion step, for a maximum daily dosage of 800 mg. However, the amountof medication or drug infused and the length of time over which it isinfused will vary greatly depending on the patient's medical history,the formula and concentration of the drug being infused, and thedifference between the sensed PADP and the pre-programmed value.

After a pre-determined period of time, for example, one hour, the PADPis again compared to the pre-programmed value (block 314). If the PADPhas dropped below the pre-programmed value, then PADP is monitored on aregular basis thereafter. If, however, the PADP has not decreased belowthe pre-programmed value, the PADP is sampled again one hour later(block 316). Because the body tends to activate therenin-angiotensis-aldosterone system upon infusion, typically causingthe PADP to increase to a peak approximately 30 minutes after infusion,the sampling delay following infusion helps to provide a more accuraterepresentation of changes in PADP. Again, if the PADP had dropped belowthe pre-programmed value, then the PADP is monitored on a regular basisthereafter. If, however, the PADP has not decreased below thepre-programmed value, then a second volume of drug is infused (block310).

This process may be repeated until the relationship between thediastolic pressure and the pre-programmed value is such that no furtherchange in IMD operating parameter is desired. In one embodiment, thehourly sampling and bi-hourly infusing regime is continued until amaximum dosage has been achieved. The control module may be furtherprovided with the ability to administer variable quantities of drug,variable rates of infusion, and variable concentrations of medication.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. Accordingly, the scope of the present invention is intendedto embrace all such alternatives, modifications, and variations as fallwithin the scope of the claims, together with all equivalents thereof.

1. A system for administering a therapeutic treatment, the systemcomprising: a pressure sensor adapted for positioning in the pulmonaryartery and collecting data representative of at least one of systolicpressure, diastolic pressure, pulse pressure, heart rate or pre-ejectionperiod based on pressure in the pulmonary artery; an implantable medicaldevice located remotely from the sensor; a control module operativelycoupled to the implantable medical device; and communication means forcommunicating pressure data from the pressure sensor to the controlmodule, wherein the control module is adapted for relating the at leastone of systolic pressure, diastolic pressure, pulse pressure, heart rateor pre-ejection period to a pre-programmed value, adjusting an operatingparameter of the implantable medical device based on the relationship ofthe at least one of systolic pressure, diastolic pressure, pulsepressure, heart rate or pre-ejection period to the pre-programmed value,and repeating this process until the relationship is such that noadjustment is necessary.
 2. The system of claim 1, wherein the deviceoperating parameter is one of timing, amplitude or site of electricalstimulation.
 3. The system of claim 1, wherein the device operatingparameter is an infusion rate or volume of a stored therapeuticmedication.
 4. The system of claim 1, wherein the communication meansincludes a radio frequency communicator operatively coupled with thepressure sensor and the implantable medical device.
 5. The system ofclaim 1, wherein the communication means includes an ultrasoundcommunicator operatively coupled to the pressure sensor and theimplantable medical device.
 6. The system of claim 1, wherein thecommunication means includes an acoustic communicator operativelycoupled with the pressure sensor and the implantable medical device. 7.The system of claim 1, wherein the communication means is a physicalconnection between the pressure sensor and the implantable medicaldevice.
 8. The system of claim 1, further including an external devicein communication with the processor and the implantable medical device.9. The system of claim 1, wherein the implantable medical device is oneof a pulse generator, a pacemaker, a defibrillator or a drug pump. 10.The system of claim 1, further comprising an anchor for fixing thepressure sensor in the pulmonary artery.
 11. The system of claim 1,further comprising: a second sensor positioned within the heart andadapted for measuring a physiologic parameter; and communication meansfor communicating data representative of the physiologic parameter tothe control module, wherein the control module is adapted for adjustingan operating parameter of the implantable medical device based on therelationship of the at least one of systolic pressure, diastolicpressure, pulse pressure, heart rate or pre-ejection period to thepre-programmed value in conjunction with the physiologic parameter data.12. A system for administering a therapeutic treatment, the systemcomprising: a pressure sensor adapted for positioning in the pulmonaryartery and collecting data representative of mean pulmonary arterypressure based on pressure in the pulmonary artery; an implantablemedical device located remotely from the sensor; a control moduleoperatively coupled to the implantable medical device; and communicationmeans for communicating pressure data from the pressure sensor to thecontrol module, wherein the control module is adapted for relating themean pulmonary artery pressure to a pre-programmed value, adjusting anoperating parameter of the implantable medical device based on therelationship of the mean pulmonary artery pressure to the pre-programmedvalue, and repeating this process until the relationship is such that noadjustment is necessary.
 13. The system of claim 12, wherein the deviceoperating parameter is one of timing, amplitude or site of electricalstimulation.
 14. The system of claim 12, wherein the device operatingparameter is an infusion rate or volume of a stored therapeuticmedication.
 15. The system of claim 12, further including an externaldevice in communication with the processor and the implantable medicaldevice.
 16. The system of claim 12, wherein the implantable medicaldevice is one of a pulse generator, a pacemaker, a defibrillator or adrug pump.
 17. The system of claim 12, further comprising an anchor forfixing the pressure sensor in the pulmonary artery.
 18. The system ofclaim 12, further comprising: a second sensor positioned within theheart and adapted for measuring a physiologic parameter; andcommunication means for communicating data representative of thephysiologic parameter to the control module, wherein the control moduleis adapted for adjusting an operating parameter of the implantablemedical device based on the relationship of the mean pulmonary arterypressure to the pre-programmed value in conjunction with the physiologicparameter data.
 19. The system of claim 12, wherein said communicationmeans is configured to wirelessly communicate data to the controlmodule.
 20. A method of administering a cardiac rhythm managementtherapy to the heart, the method comprising: sensing a number ofpulmonary artery pressure readings from within the pulmonary artery;determining a mean pulmonary artery pressure from the pulmonary arterypressure readings; communicating data representative of the meanpulmonary artery pressure from the sensor to an implantable medicaldevice; comparing the mean pulmonary artery pressure to a pre-programmedvalue; limiting increases in the heart's pacing rate by sending acardiac rhythm management signal to the heart to maintain the meanpulmonary artery pressure below the pre-programmed value; and repeatingthe process until the relationship between the mean pulmonary arterypressure and the pre-programmed value is such that no adjustment isnecessary.